Stelara
What Stelara is used for
Adult Crohn’s Disease Stelara is indicated for the treatment of adult patients with moderately to severely active Crohn’s disease who have had an inadequate response with, lost response to, or were intolerant to either conventional therapy or a TNFα antagonist. Paediatric Crohn's Disease Stelara is indicated for the treatment of moderately to severely active Crohn’s disease in paediatric patients from the age of 2 years and older, who have had an inadequate response to, or were intolerant to either conventional or biologic therapy. Adult ulcerative colitis Stelara is indicated for the treatment of adult patients with moderately to severely active ulcerative colitis who have had an inadequate response with, lost response to, or were intolerant to either conventional therapy or a biologic. Paediatric ulcerative colitis Stelara is indicated for the treatment of moderately to severely active ulcerative colitis in paediatric patients from the age of 2 years and older, who have had an inadequate response to, or were intolerant to either conventional therapy or a biologic. Plaque psoriasis Stelara is indicated for the treatment of moderate to severe plaque psoriasis in adults who failed to respond to, or who have a contraindication to, or are intolerant to other systemic therapies including ciclosporin, methotrexate (MTX) or PUVA (psoralen and ultraviolet A) (see section 5.1). Paediatric plaque psoriasis Stelara is indicated for the treatment of moderate to severe plaque psoriasis in children and adolescent patients from the age of 6 years and older, who are inadequately controlled by, or are intolerant to, other systemic therapies or phototherapies. Psoriatic arthritis (PsA) Stelara, alone or in combination with MTX, is indicated for the treatment of active psoriatic arthritis in adult patients when the response to previous non-biological disease modifying anti rheumatic drug (DMARD) therapy has been inadequate (see section 5.1).
Approved use, as published by the European Medicines Agency.
Key facts
- Brand
- Stelara
- Active substance
- ustekinumab
- Disease area
- Psoriasis; Arthritis, Psoriatic; Crohn Disease; Colitis, Ulcerative
- Medicine group
- Immunosuppressants
- ATC code
- L04AC05
- Marketing authorisation holder
- Janssen-Cilag International NV
- Authorised in the EU since
- 2009
Official information
In the USA
Same active substance: Starjemza, Pyzchiva, Stelara, Yesintek, Selarsdi, Otulfi, Wezlana, Steqeyma
Specialist medicine: started and supervised by a specialist doctor or hospital. This page is a plain-language summary of public official information, not medical advice; follow your doctor and the official product information.
Common questions
What is Stelara used for?
Adult Crohn’s Disease Stelara is indicated for the treatment of adult patients with moderately to severely active Crohn’s disease who have had an inadequate response with, lost response to, or were intolerant to either conventional therapy or a TNFα antagonist. Paediatric Crohn's Disease Stelara is indicated for the treatment of moderately to severely active Crohn’s disease in paediatric patients from the age of 2 years and older, who have had an inadequate response to, or were intolerant to either conventional or biologic therapy. Adult ulcerative colitis Stelara is indicated for the treatmen…
What is the active substance in Stelara?
Stelara contains ustekinumab.
Who makes Stelara?
The EU marketing authorisation holder is Janssen-Cilag International NV.
Source: European Medicines Agency medicines data (ema.europa.eu), reproduced with acknowledgement of the source. Page made 5 November 2026 by Satya Babu.
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